Tag Archives: fda

no preemption of state claims where FDA didn’t regulate cosmetic talc at all

Posted on August 11, 2021 by rtushnet

Johnson & Johnson v. Fitch, No. 2019-IA-00033-SCT, — So.3d —-, 2021 WL 1220579 (Miss. Apr. 1, 2021) The Mississippi AG sued J&J under the Mississippi Consumer Protection Act for selling talcum powder products, alleging that J&J failed to warn of … Continue reading →

Posted in Uncategorized | Tagged , , , | Leave a comment

prescription and OTC products can directly compete; many non-FDCA-based claims survive

Posted on August 9, 2021 by rtushnet

Scilex Pharmaceuticals Inc. v. Sanofi-Aventis U.S. LLC, 2021 WL 3417590, — F.Supp.3d —-, 2021 WL 3417590, No. 21-cv-01280-JST (N.D. Cal. Aug. 5, 2021) Scilex sells an FDA-approved, prescription-strength topical analgesic self-adhesive patch, ZTlido (lidocaine), which is allegedly often prescribed off-label, … Continue reading →

Posted in Uncategorized | Tagged , , , | Leave a comment

FDA preemption/preclusion after Pom Wonderful: still powerful for drugs

Posted on September 21, 2020 by rtushnet

Exela Pharma Sciences, LLC v. Sandoz, Inc., 2020 WL 5535026, No. 19-cv-00318-MR (W.D.N.C. Sept. 15, 2020) Exela sued Sandoz for unfair and deceptive trade practices in violation of North Carolina law; tortious interference with prospective business advantage; and Lanham Act … Continue reading →

Posted in Uncategorized | Tagged , , | Leave a comment

I can’t believe it’s not (vegan) butter: First Amendment invalidates standard of identity for butter as applied to vegan product

Posted on September 8, 2020 by rtushnet

Miyoko’s Kitchen v. Ross, No. 20-cv-00893-RS (N.D. Cal. Aug. 21, 2020) Eric Goldman’s far more anti-regulatory take is here. The California Department of Food and Agriculture told Miyoko’s not to call its “vegan butter” product “butter” (it challenged certain other … Continue reading →

Posted in Uncategorized | Tagged , , | Leave a comment

context matters: “mineral-based” sunscreen with chemical-based active ingredients is plausibly deceptive

Posted on August 7, 2020 by rtushnet

Prescott v. Bayer Healthcare LLC, 2020 WL 4430958, No. 20-cv-00102-NC (N.D. Cal. Jun. 31, 2020) (magistrate) Plaintiffs alleged that defendants deceived consumers by labeling their sunscreens as “mineral-based” when the sunscreens contain active chemical ingredients. As the court explains,   … Continue reading →

Posted in Uncategorized | Tagged , , , , | Leave a comment

“100% Natural” might be deceptive as applied to food w/bioengineered ingredients

Posted on May 11, 2020 by rtushnet

Lee v. Conagra Brands, Inc., No. 17-2131 (1st Cir. May 7, 2020) Lee alleged that Wesson’s supposedly “100% Natural” vegetable oil contained GMOs, which she regarded as “quite unnatural,” in violation of Mass. Gen. Laws ch. 93A.  She also alleged … Continue reading →

Posted in Uncategorized | Tagged , , , | Leave a comment

“complete” vitamin is plausibly deceptive where essential nutrients are lacking

Posted on March 10, 2020 by rtushnet

Devane v. Church & Dwight Co., No. 3:19-cv-09899-BRM-LHG, 2020 WL 998946 (D.N.J. Feb. 28, 2020) Plaintiffs brought consumer protection claims based on Church & Dwight’s purportedly false labelling of several multivitamins, including L’il Critters Multivitamins, Vitafusion Women’s Complete Multivitamins, and … Continue reading →

Posted in Uncategorized | Tagged , , | Leave a comment

FDA/FTC Workshop on a Competitive Marketplace for Biosimilars

Posted on March 9, 2020 by rtushnet

FDA Licensure Process and U.S. Biosimilar Markets   [I entered in media res] · Eva Temkin, Acting Director for Policy, Office of Therapeutic Biologics and Biosimilars,  CDER, FDA   · Christine Simmon, Executive Director, Biosimilars Council, AAM: barriers to entry for … Continue reading →

Posted in Uncategorized | Tagged , , , , | Leave a comment

labeling grandfathered drug in standard format doesn’t misrepresent it as FDA-approved

Posted on January 14, 2020 by rtushnet

Belcher Pharms., LLC v. Hospira, Inc., — F. Supp. 3d –, No. 8:17-cv-2353-T-30AAS, 2020 WL 102744 (M.D. Fla. Jan. 7, 2020) “Epinephrine—a drug that is a medical necessity—has been in short supply on and off for nearly a decade.” Hospira … Continue reading →

Posted in Uncategorized | Tagged , | Leave a comment

court enjoins bar on “fake meat” labels; implications for FDA standards of identity?

Posted on December 16, 2019 by rtushnet

Turtle Island Foods SPC v. Soman, No. 4:19-cv-00514-KGB (E.D. Ark. Dec. 11, 2019) Unsurprisingly, the court here enjoins provisions of Arkansas law that tried to restrict the use of “meat” terms for meatless alternatives. The worrying part is that the … Continue reading →

Posted in Uncategorized | Tagged , , , | Leave a comment